BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Parcus Graft Fixation System Standard and Large

    Reg #: 1064017 · FEI: 3000190635 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    AME INT'L.
    Registration Number
    1064017
    FEI Number
    3000190635
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7440 SOUTH WEST 50 TERR., No. 108
    City
    MIAMI
    State
    FL
    ZIP
    33155
    Country
    US

    Regulatory Submissions

    510(k) Number
    K090923

    Owner / Operator

    Firm Name
    AME INT'L.
    Operator Number
    9036247
    Address
    7440 SOUTH WEST 50 TERR., #108, --
    City
    Miami
    State
    FL
    Postal Code
    33155
    Country
    US
    Correspondent
    VICTOR - FERNANDEZ

    Products

    Device Name Product Code
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Fastener, Fixation, Nondegradable, Soft Tissue MBI

    Proprietary Names

    Parcus Graft Fixation System Standard and Large

    Establishment Types

    Repack or Relabel Medical Device